Manipal Group-backed Stempeutics Research has signed a licensing agreement with Tokyo-listed Medinet to bring its stem cell therapy Stempeucel to the Japanese market for treating Critical Limb-Threatening Ischemia (CLTI). This partnership represents the first time an Indian company has licensed its cell therapy product to a Japanese firm, marking a significant milestone in international regenerative medicine collaboration.
Licensing Agreement Details
Under the agreement, Medinet will develop and commercialize Stempeucel in Japan, subject to regulatory approval from the Pharmaceuticals and Medical Devices Agency (PMDA). Stempeutics will receive an upfront fee, with additional milestone payments and royalties if Medinet opts to license the product. The drug will be manufactured at Stempeutics's cGMP facility in Bengaluru and shipped to Japan for clinical trials and subsequent commercialization.
Addressing Critical Medical Need
CLTI is a critical form of peripheral arterial disease that often results in limb amputation due to severely reduced blood flow to the limbs. Current vascular treatments only work in about 25% of cases, highlighting a significant unmet medical need. Stempeucel aims to improve patient outcomes by restoring blood flow through anti-inflammatory and angiogenic mechanisms.
Innovative Stem Cell Technology
Stempeucel is a stem cell therapy made from pooled mesenchymal stromal cells (MSCs) of healthy donors. The proprietary pooling process improves consistency, immune-modulatory strength, and clinical efficacy, which serve as key differentiators in the global cell therapy space. The therapy has already treated over 600 CLTI patients in India and is a patented product in Japan.
Strategic Significance
"Signing a licensing agreement with a Japanese regenerative medicine company is an important milestone for Stempeutics," said BN Manohar, CEO of Stempeutics. He emphasized that the deal highlights their global leadership in allogeneic, pooled MSC technology.
Kanenao Kubushiro, President of Medinet, expressed confidence in the therapy's potential: "We believe this therapy can make a real difference for Japanese patients suffering from this painful and serious condition."
Company Background
Founded in 2006, Stempeutics has developed a strong portfolio of cell-based and acellular therapies. The company has established marketing partnerships with Cipla and Alkem in India and has licensed its technology to several international markets. Dr. Pawan Kumar Gupta, President of Medical & Regulatory Affairs at Stempeutics, emphasized that "Stempeucel offers hope for a new, effective treatment and a better quality of life" for patients with this serious condition.
